Codman Certas Valve Recalled for Pressure Specification Clarification
Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the Instructions for Use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a Class II recall focused on clarifying pressure specifications in the Instructions for Use, which aligns with the rubric for minor labeling or documentation issues without reported injuries.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 9,498 units of the Codman Certas In Line Valve with SIPHONGUARD Device (Product Code: 82-8804). The recall is initiated to clarify the pressure specification for the 'virtual off' (setting 8) as outlined in the product's Instructions for Use (IFU). The Codman Certas Programmable valve is an implantable device used to provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus.
The affected devices were distributed worldwide, including in the United States and various international markets such as Canada, Australia, and numerous European and Middle Eastern countries. Specific lot numbers are listed in the recall documentation.
Healthcare providers and patients should contact Codman & Shurtleff for further information regarding this clarification and any necessary actions related to the device's pressure settings.
The recalled product
- Product
- Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82-8804 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
- Manufacturer
- Codman & Shurtleff, Inc.
- Affected units
- 9,498
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: CMBC2W
- CMDBHB
- CMDDJP
- CMDDJR
- CMKB22
- CMLCKR
- CMMB1L
- CMMCR5
- CMNBFD
- CMNCVP
- CMNCYM
- CMPB95
- CMPBMD
- CNBB13
- CNBBCZ
- CNCB4R
- CNCB61
- CNCB6L
- CNDB8B
- CNDBVZ
Distribution
Part of a larger recall action
This product is one of 8 recalled by Codman & Shurtleff, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · Codman & Shurtleff, Inc.
See all →- ModerateCodman Galaxy G3 Mini Microcoil Delivery System Recalled for Labeling Error
FDA (Devices) · 2019-08-21
- HighCodman 3000 Series Refill Set Recalled for Leaking Needles
FDA (Devices) · 2015-06-03
- HighCodman EDS 3 Drainage System Recalled for Tubing Leak Risk
FDA (Devices) · 2014-10-29
- SevereCodman EDS 3 Drainage System Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29
- SevereCodman Lumbar Drainage Catheter Kit Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29